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Compassionate Use Study of Pergolide in Patients With Parkinson's Disease

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00624741
First Posted: February 27, 2008
Last Update Posted: June 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
  Purpose
This compassionate use study is designed to monitor safety in patients who have been doing well on pergolide therapy, wish to continue treatment, and have not been able to tolerate alternative treatments.

Condition Intervention
Parkinson Disease Drug: Pergolide

Study Type: Expanded Access     What is Expanded Access?
Official Title: Compassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Intervention Details:
    Drug: Pergolide
    Pergolide tablets should be initiated with a daily dosage of 0.05 mg for the first 2 days. The dosage should then be gradually increased by 0.1 or 0.15 mg/day every third day over the next 12 days of therapy. The dosage may then be increased by 0.25 mg/day every third day until an optimal therapeutic dosage is achieved.
    Other Name: Permax
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Diagnosed with Parkinson's disease and treated successfully with pergolide in the recent past
  • Attempt to taper off pergolide was unsuccessful and patient was unable to change to other forms of therapy for Parkinson's disease
  • No evidence of cardiovalvular disease by echocardiogram conducted within 60 days prior

Exclusion Criteria:

  • History or current diagnosis of cardiac valvulopathy
  • Inability to undergo echocardiograms every 6 months while receiving pergolide
  • Hypersensitivity to pergolide or other ergot derivatives
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT00624741     History of Changes
Other Study ID Numbers: PRG-001
First Submitted: February 15, 2008
First Posted: February 27, 2008
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Parkinson's disease
Antiparkinsonian
Compassionate use

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pergolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs